Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Monaghan medical filtered mouthpiece kit

K-Number: K220145 · 2023-08-24

Decision Date2023-08-24
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Monaghan medical filtered mouthpiece kit is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corporation. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K220145. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monaghan medical filtered mouthpiece kit?

Monaghan medical filtered mouthpiece kit is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Monaghan Medical Corporation. The 510(k) number is K220145.

When did Monaghan medical filtered mouthpiece kit receive FDA 510(k) clearance?

Monaghan medical filtered mouthpiece kit received FDA 510(k) clearance on 2023-08-24, under 510(k) number K220145.

Who is the listed applicant for Monaghan medical filtered mouthpiece kit?

The FDA 510(k) record lists Monaghan Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monaghan medical filtered mouthpiece kit?

The FDA product code for Monaghan medical filtered mouthpiece kit is CAF.

Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.